达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.431562631563221564741560961564431563200.10
212.551609081609451609260.02
单位质量响应值RSD%判断
12576.0312822.791.38数据可信
供试品溶液-24110601批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1154030-15403078.02182.844.9378.0282.844.93
2159891-15989180.98980.99
3173407-17340787.83687.84
4164005-16400583.07383.07
5157273-15727379.66379.66
6172705-17270587.48087.48
10min1168138-16813885.16788.954.3585.2889.074.35
2171527-17152786.88387.00
3184899-18489993.65793.79
4174947-17494788.61688.74
5169073-16907385.64085.76
6185020-18502093.71893.85
15min1173530-17353087.89891.364.2388.1491.624.23
2175886-17588689.09189.34
3189325-18932595.89896.17
4179868-17986891.10891.37
5173470-17347087.86788.12
6190146-19014696.31496.59
20min1175544-17554488.91892.284.2689.2992.684.26
2177639-17763989.97990.36
3191002-19100296.74897.16
4182427-18242792.40492.80
5174437-17443788.35788.74
6192069-19206997.28897.70
30min1177854-17785490.08893.344.0990.6093.884.09
2179431-17943190.88791.41
3193300-19330097.91298.47
4184644-18464493.52794.06
5176988-17698889.64990.16
6193443-19344397.98498.55
45min1179493-17949390.91893.574.0191.5694.244.01
2179861-17986191.10591.76
3193836-19383698.18398.89
4182479-18247992.43193.10
5178314-17831490.32190.97
6194375-19437598.45699.17
60min1179494-17949490.91993.973.9391.7094.783.93
2180013-18001391.18291.98
3193832-19383298.18199.04
4186143-18614394.28795.10
5178900-17890090.61891.40
6194729-19472998.63699.49
120min1179776-17977691.06293.903.7691.9894.863.77
2179516-17951690.93091.86
3193311-19331197.91798.92
4186336-18633694.38495.34
5179277-17927790.80991.73
6194067-19406798.30099.31
180min1180237-18023791.29593.643.5592.3594.733.56
2179048-17904890.69391.76
3192290-19229097.40098.55
4186127-18612794.27995.37
5178624-17862490.47891.53
6192857-19285797.68798.84
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1185108-18510893.76296.663.6094.9597.893.61
2185084-18508493.75094.95
3198530-198530100.561101.86
4192365-19236597.43898.67
5184656-18465693.53394.72
6199202-199202100.901102.20
360min1184966-18496693.69096.253.5295.0297.633.53
2183981-18398193.19294.53
3197426-197426100.002101.45
4192133-19213397.32198.70
5183716-18371693.05794.39
6197872-197872100.228101.68
480min1183858-18385893.12995.623.5294.6097.143.53
2182735-18273592.56094.04
3196141-19614199.351100.95
4191128-19112896.81298.34
5182338-18233892.35993.83
6196423-19642399.494101.09
600min1182879-18287992.63395.123.4594.2596.793.45
2182234-18223492.30793.93
3194683-19468398.612100.36
4190195-19019596.33998.01
5181306-18130691.83793.45
6195441-19544198.996100.75
720min1181868-18186892.12194.543.3693.8796.353.37
2181210-18121091.78893.55
3193486-19348698.00699.90
4189257-18925795.86497.68
5180300-18030091.32793.07
6193716-19371698.123100.02
960min1179814-17981491.08193.653.4292.9795.603.43
2179269-17926990.80592.70
3191169-19116996.83298.87
4188096-18809695.27697.24
5178695-17869590.51492.40
6192224-19222497.36799.41
1200min1178033-17803390.17992.753.3892.2094.843.38
2177755-17775590.03892.07
3188770-18877095.61797.80
4186937-18693794.68996.79
5176941-17694189.62691.64
6190273-19027396.37998.57
极限1177685-17768590.00292.643.3692.1694.873.37
2177779-17777990.05092.22
3188774-18877495.61997.95
4186226-18622694.32996.58
5176765-17676589.53691.69
6190107-19010796.29598.63
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.019319729333739339689334299342559333990.10
210.089487339514059500690.20
单位质量响应值RSD%判断
93246.6594252.880.76数据可信
供试品溶液-24110601批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137533-375334.0044.5910.084.004.5910.14
241283-412834.4044.40
350774-507745.4165.42
443241-432414.6134.61
542286-422864.5114.51
642915-429154.5784.58
10min186075-860759.1829.702.909.199.712.89
290855-908559.6929.70
392091-920919.8239.83
490595-905959.6649.67
593792-9379210.00510.01
692166-921669.8319.84
15min1128561-12856113.71414.151.7213.7314.171.74
2131899-13189914.07014.09
3132797-13279714.16514.19
4133349-13334914.22414.25
5134943-13494314.39414.42
6134312-13431214.32714.35
20min1161593-16159317.23718.014.6517.2818.054.64
2166028-16602817.71017.75
3165794-16579417.68517.73
4166528-16652817.76417.81
5168963-16896318.02318.07
6184095-18409519.63719.68
30min1216615-21661523.10623.641.2623.1723.701.27
2220753-22075323.54823.62
3221469-22146923.62423.69
4222712-22271223.75723.83
5224621-22462123.96024.03
6223277-22327723.81723.89
45min1281961-28196130.07730.881.9030.1830.981.89
2298592-29859231.85131.95
3286478-28647830.55930.66
4289366-28936630.86730.97
5289996-28999630.93431.04
6290661-29066131.00531.11
60min1335451-33545135.78336.631.3635.9336.781.36
2349019-34901937.23037.38
3340966-34096636.37136.52
4344677-34467736.76736.92
5344359-34435936.73336.89
6345666-34566636.87237.03
120min1492631-49263152.54953.511.0852.7553.721.08
2501041-50104153.44653.65
3498968-49896853.22553.43
4507497-50749754.13554.34
5506085-50608553.98454.19
6503609-50360953.72053.93
180min1607282-60728264.77965.631.0065.0665.921.00
2613962-61396265.49165.78
3611141-61114165.19065.48
4624201-62420166.58466.87
5620341-62034166.17266.46
6614570-61457065.55665.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1712406-71240675.99277.101.2676.3777.481.26
2722588-72258877.07877.46
3715299-71529976.30176.69
4737000-73700078.61679.00
5729055-72905577.76878.16
6720155-72015576.81977.21
360min1837419-83741989.32789.881.2489.8290.381.23
2841075-84107589.71790.22
3831449-83144988.69189.19
4859617-85961791.69592.20
5849907-84990790.66091.16
6836059-83605989.18289.69
480min1907418-90741896.79497.351.7197.4297.981.70
2910231-91023197.09497.73
3898279-89827995.81996.45
4941186-941186100.396101.04
5917448-91744897.86498.50
6901205-90120596.13296.77
600min1944842-944842100.786101.091.64101.56101.881.64
2945535-945535100.860101.64
3929909-92990999.19399.97
4968637-968637103.325104.12
5963492-963492102.776103.56
6933991-93399199.629100.41
720min1959401-959401102.339102.221.55103.26103.151.54
2957133-957133102.097103.03
3942597-942597100.547101.47
4981576-981576104.705105.65
5966137-966137103.058104.00
6942884-942884100.577101.51
960min1963569-963569102.784102.792.08103.86103.882.07
2959143-959143102.312103.40
3944461-944461100.746101.82
4999379-999379106.604107.71
5969311-969311103.396104.49
6946066-946066100.917102.00
1200min1957031-957031102.087102.091.75103.31103.341.74
2954852-954852101.854103.09
3938597-938597100.120101.35
4984399-984399105.006106.27
5965642-965642103.005104.26
6942102-942102100.494101.73
极限1957414-957414102.127102.021.74103.51103.411.73
2954877-954877101.857103.25
3937968-937968100.053101.43
4983115-983115104.869106.29
5964518-964518102.885104.29
6940500-940500100.323101.71
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.431577631580671578841578181579181578900.08
212.551587771587791587780.01
单位质量响应值RSD%判断
12702.3312651.630.29数据可信
供试品溶液-TL3535批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1100067-10006750.77251.5317.1950.7751.5417.19
2110264-11026455.94655.95
3111152-11115256.39656.40
466992-6699233.99033.99
5110466-11046656.04856.05
6110463-11046356.04756.05
10min1151379-15137976.80680.0310.3276.8880.1110.33
2172821-17282187.68687.77
3164184-16418483.30383.39
4127703-12770364.79464.84
5166091-16609184.27184.36
6164199-16419983.31183.40
15min1168867-16886785.67988.717.1785.8788.917.18
2187429-18742995.09795.31
3178801-17880190.72090.93
4152387-15238777.31877.47
5180392-18039291.52791.74
6181157-18115791.91592.12
20min1174816-17481688.69891.535.8389.0291.865.84
2191811-19181197.32197.68
3183390-18339093.04893.39
4162074-16207482.23382.50
5184347-18434793.53493.88
6185897-18589794.32094.67
30min1181649-18164992.16594.374.3092.6294.844.33
2194890-19489098.88399.39
3188400-18840095.59096.08
4172251-17225187.39687.78
5188005-18800595.39095.88
6190760-19076096.78797.28
45min1185856-18585694.29996.313.3194.8996.923.34
2196438-19643899.668100.32
3192125-19212597.48098.11
4179483-17948391.06691.58
5190261-19026196.53497.17
6194794-19479498.83499.47
60min1188575-18857595.67997.532.5596.4198.292.59
2196518-19651899.709100.51
3195181-19518199.03199.81
4184448-18444893.58594.24
5192083-19208397.45998.23
6196578-19657899.739100.52
120min1189557-18955796.17798.371.7797.0599.271.80
2196174-19617499.534100.49
3198013-198013100.467101.39
4190055-19005596.43097.23
5193813-19381398.33799.26
6195640-19564099.263100.19
180min1190971-19097196.89598.401.6097.9199.441.63
2195045-19504598.962100.06
3198160-198160100.542101.62
4190171-19017196.48997.43
5193033-19303397.94199.01
6196210-19621099.553100.63
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1196968-19696899.937101.921.50101.10103.121.52
2202362-202362102.674103.92
3205398-205398104.214105.44
4198410-198410100.669101.75
5200429-200429101.693102.91
6201745-201745102.361103.59
360min1195502-19550299.193101.501.66100.51102.851.68
2200308-200308101.632103.04
3204842-204842103.932105.31
4197800-197800100.359101.60
5199427-199427101.185102.55
6202422-202422102.705104.09
480min1194788-19478898.831101.151.59100.30102.651.60
2199631-199631101.288102.84
3204171-204171103.592105.13
4197460-197460100.187101.57
5199331-199331101.136102.66
6200729-200729101.846103.38
600min1194008-19400898.435100.671.61100.05102.321.62
2198651-198651100.791102.50
3203512-203512103.258104.95
4196846-19684699.875101.41
5197616-197616100.266101.94
6199825-199825101.387103.08
720min1192162-19216297.499100.131.6699.26101.931.67
2198423-198423100.676102.53
3201818-201818102.398104.25
4195800-19580099.345101.03
5196877-19687799.891101.71
6198950-198950100.943102.79
960min1191663-19166397.24699.351.4899.15101.301.49
2196021-19602199.457101.47
3200246-200246101.600103.60
4194402-19440298.635100.47
5195197-19519799.039101.01
6197346-197346100.129102.12
1200min1190094-19009496.45098.421.3098.50100.521.33
2194990-19499098.934101.09
3197334-197334100.123102.28
4192478-19247897.65999.64
5193641-19364198.249100.37
6195287-19528799.084101.23
极限1190200-19020096.50398.431.3998.70100.681.41
2194206-19420698.536100.84
3198165-198165100.545102.85
4192384-19238497.61199.74
5193818-19381898.339100.61
6195184-19518499.032101.32
达格列净二甲双胍片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.019449489463539458229466099458839459230.07
210.089437469447259442360.08
单位质量响应值RSD%判断
94497.8093674.210.62数据可信
供试品溶液-TL3535批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129037-290373.0862.868.893.092.868.92
226624-266242.8302.83
327050-270502.8752.88
430114-301143.2013.20
523875-238752.5382.54
624785-247852.6342.63
10min171330-713307.5827.154.577.597.154.60
266963-669637.1177.12
367925-679257.2207.22
462937-629376.6896.69
564792-647926.8876.89
669558-695587.3937.40
15min1108815-10881511.56611.033.8711.5811.043.87
2106676-10667611.33811.35
3104593-10459311.11711.13
497263-9726310.33810.35
5102071-10207110.84910.86
6103091-10309110.95710.97
20min1141004-14100414.98714.254.6715.0214.284.66
2138501-13850114.72114.75
3135254-13525414.37614.41
4122954-12295413.06913.10
5132407-13240714.07314.10
6134196-13419614.26314.29
30min1194278-19427820.64919.794.4220.7119.844.43
2194085-19408520.62920.68
3186746-18674619.84919.90
4171831-17183118.26418.31
5184176-18417619.57619.63
6185903-18590319.75919.81
45min1257703-25770327.39126.393.6227.4826.483.62
2255080-25508027.11227.20
3249857-24985726.55726.64
4232094-23209424.66924.75
5246600-24660026.21126.29
6248444-24844426.40726.49
60min1310670-31067033.02032.023.0233.1532.143.02
2308304-30830432.76932.89
3304662-30466232.38232.50
4285506-28550630.34630.46
5297576-29757631.62931.75
6300898-30089831.98232.10
120min1461317-46131749.03248.251.7849.2148.421.78
2463638-46363849.27949.45
3456493-45649348.52048.69
4442297-44229747.01147.17
5449187-44918747.74347.91
6450604-45060447.89448.06
180min1574723-57472361.08659.961.5061.3460.201.50
2572253-57225360.82361.07
3565920-56592060.15060.39
4553590-55359058.84059.07
5556652-55665259.16559.40
6561819-56181959.71459.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1680094-68009472.28671.421.0972.6371.751.10
2680960-68096072.37872.72
3673388-67338871.57371.91
4666516-66651670.84271.16
5665076-66507670.68971.02
6665601-66560170.74571.08
360min1803133-80313385.36384.820.7285.8185.260.72
2803920-80392085.44785.90
3800993-80099385.13685.58
4796534-79653484.66285.09
5789377-78937783.90184.34
6793918-79391884.38484.82
480min1881021-88102193.64293.430.6494.2293.990.64
2885849-88584994.15594.73
3881937-88193793.73994.31
4880714-88071493.60994.16
5870961-87096192.57393.13
6873513-87351392.84493.41
600min1924839-92483998.29998.190.7399.0298.890.73
2932037-93203799.06499.78
3926237-92623798.44899.16
4927501-92750198.58299.27
5913191-91319197.06197.76
6918801-91880197.65798.36
720min1940682-94068299.983100.260.76100.85101.120.76
2953985-953985101.397102.26
3943941-943941100.329101.19
4948345-948345100.797101.64
5933894-93389499.262100.11
6939080-93908099.813100.66
960min1953063-953063101.299101.230.75102.32102.230.75
2961701-961701102.217103.24
3951851-951851101.170102.18
4958202-958202101.845102.84
5942255-942255100.150101.14
6947273-947273100.684101.68
1200min1949900-949900100.963100.940.80102.13102.100.80
2962218-962218102.272103.44
3945587-945587100.504101.66
4954302-954302101.431102.57
5941471-941471100.067101.21
6944748-944748100.415101.57
极限1949486-949486100.919101.040.59102.24102.350.59
2958744-958744101.903103.23
3948802-948802100.846102.16
4955609-955609101.570102.87
5947137-947137100.669101.96
6943879-943879100.323101.62
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